Effects of Non-ablative Radiofrequency on Female Genito-pelvic Pain Disorder: Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Penetration capacity with reduced vaginal pain
研究概览
简要总结
The goal of this randomized clinical trial is to verify the response of genito-pelvic pain disorders in women associated with inability to penetrate to the treatment with non-ablative radiofrequency. The main question it aims to answer is: Does non-ablative radiofrequency have a positive effect on the symptoms of genito-pelvic pain disorders associated with inability to penetrate? Before starting the intervention and at one week, one-, three- and six months after the end of the study, participants will be evaluated with 03 questionnaires (Female Sexual Function Index, Sexual Quality of Life and Perceived Stress Scale-10) and will score the visual analogue scale the level of pain with the penetration (from 0 to 10); participants will then undergo digital evaluation of the pelvic floor muscles, using vaginal dilators and electromyographic evaluation. After being randomized, participants will be divided into the Experimental Group and the Sham Group, being submitted to • the use of non-ablative radiofrequency in the anal and urogenital triangles, • the positioning of the vaginal dilator at the end of each session • and participants will be instructed to use the vaginal dilator at home daily. The researchers will compare the groups in relation to the ability to penetrate with reduced vaginal pain, sexual function, quality of sexual life and the correlation between pelvic muscle activity and perceived stress.
详细描述
Initially, all women included in the study will be briefly and clearly instructed about genito-pelvic pain dysfunction and the anatomy of the pelvic floor. Then the participants will respond to the questionnaires FSFI (Female Sexual Function Index), SQoL-F (Scale of Female Sexual Quality of Life) and the PSS-10 (Perceived Stress Scale - 10).
The FSFI assesses the female sexual function index in the following domains: desire, arousal, lubrication, orgasm, satisfaction and pain. It is self-administered, contains 19 items, with an average response time of nine minutes and addresses aspects of the last four weeks. It is a measure to be considered a potential "gold standard" for evaluating therapeutically induced changes in female sexual function.
The SQoL-F measures the impact of female sexual dysfunctions on women's quality of life, addressing the items: psychosexual feelings, sexual and relationship satisfaction, self-invalidation and sexual repression. It is self-administered, contains 18 items, with an average response time of seven minutes and addresses aspects of the last four weeks.
The EPS-10 measures the degree of stress perceived by individuals within 30 days. It is validated in several countries in versions with 14 questions, 10 questions and four questions. The version with 10 questions was chosen for this study and is self-administered. The scale checks how much respondents evaluate their lives in terms of unpredictability, overload and lack of control, factors recognized as the most relevant factors in cases of stress.
After completing this first process, an Admission Form will be completed in two consecutive stages. In the first stage, the participant will be taken to a reserved location accompanied by at least one properly trained researcher, where questions 1 to 23 of the Admission Form will be answered, in which the following will be collected: demographic data, data social conditions, comorbidities, history of current and previous illness, gynecological history, obstetric history and fecal history, with application of the Rome III Criteria, Bristol Scale, and Visual Analogue Scale (VAS) related to pain during vaginal penetration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with genito-pelvic pain disorder associated to penetration.
排除标准
- •Chronic degenerative disease
- •Cognitive impairment
- •Genital agenesis
- •History of vaginal cancer or genital radiotherapy
- •Pelvic or lumbosacral prostheses
- •Cardiac pacemakers
- •Pregnant women
- •Infections in the genital or systemic region
- •Any type of treatment for genito-pelvic pain disorder
- •Unstable relationship with the same partner
- •Partner with sexual complaints.
结局指标
主要结局
Penetration capacity with reduced vaginal pain
时间窗: From enrollment till 6 months after the end of treatment: at the assessment, before each session (8 sessions, one per week), one week after the last session, one, three and six months after the end of the treatment
To assess the primary outcome it will be used the Visual Analogue Scale (VAS) related to pain during vaginal penile penetration and during the vaginal dilatator penetration. The score varies from 0 (no pain) to 10 (maximum pain). Diminishing at least 2 points on the scale means positive diffence with the treatment. Also the change of the size of the vaginal dilatator will be a measure to positive response to the treatment. There are 6 sizes: green nº 1: diameter 1.16cm, length 6.5cm; rose nº 2: diameter 1.90cm, length 7.5cm; yellow nº 3: diameter 2.15cm, length 8.7cm; purple nº 4: diameter 2.5cm, length 10.9cm; blue nº 5: diameter 3.10cm, length 13.20cm; and orange nº 6: diameter 3.5cm, length 14.5cm
次要结局
- Quality of sexual life(From enrollment till 6 months after the end of treatment: at the assessment, before each session (8 sessions, one per week), one week after the last session, one, three and six months after the end of the treatment)
- Stress perception(From enrollment till 6 months after the end of treatment: at the assessment, before each session (8 sessions, one per week), one week after the last session, one, three and six months after the end of the treatment)
- Sexual function(From enrollment till 6 months after the end of treatment: at the assessment, before each session (8 sessions, one per week), one week after the last session, one, three and six months after the end of the treatment)
研究者
Patricia Lordelo
Head of the CentroAAP
Centro de Atenção ao Assoalho Pélvico